Additional new gout drugs being developed

There is now a lot of gout research going on into new gout drugs at a practical level. That is, to produce drugs that work better than existing ones. Here's a round up.

This page was last edited and extended on 10 November 2009.

ARCALYST (RILONACEPT)

This new gout drug, like pegloticase, offers something really new in gout treatment. It has been formulated to deal with the pain of gout attacks. Before you read any more you need to know that arcalyst is under development. Like pegloticase, it has not been approved and in fact it's at least about 3 years away from any possibility of approval. But it has completed phase one and two trials and its developers intend to start phase 3 trials early in 2009.

Why do gout attacks occur when uric acid levels are falling and the MSU gout crystals are being dissolved? This very pertinent question is one of many at the heart of the whole gout puzzle. There are others, but this is the one that arcalyst addresses.

Neither colchicine nor NSAIDs were found to be helpful with gout pain with this question fully understood. Arcalyst does tackle this question and in a more accurate way. And it developers say, for the very first time in a practical way. i.e. the theory has been turned into a potential remedy.

You would need to be a biochemist, and know a lot about cell behaviour, to understand it at a root level, and so would I. Simply put, the theory arcalyst works on is that a protein called Interleukin-1 (IL-1) is a leading cause of inflammation. The problem during attacks and falling uric acid levels, is that excess IL-1 is excreted from some cells. IL-1 enters the bloodstream before connecting itself to cell surfaces where it causes pain and inflammation. Arcalyst inhibits its attachment to cell surfaces by joining itself to IL-1 in the blood. Both are excreted from the body.

Arcalyst has not worked for everyone who took it in a phase two trial. But in this trial, among patients treated with arcalyst, only about 15% suffered attacks in a 12 week period. No patient had more than one attack during this time. Serious arcalyst related adverse effects did not occur.

The main hope seems to be that arcalyst will work better than colchicine and NSAIDs in reducing the pain of gout attacks, and during falling uric acid levels. The medical world calls this prophylaxis. And work for those who can't tolerate colchicine and NSAIDs. If it's successfully developed and approved, it is likely to be used in tandem with medications like allopurinol or febuxostat.

In 2009 there was another phase 2 study of it with patients who also mainly took allopurinol at 300 mg.(The standard allopurinol dose). The number of patients suffering a gout flare during this 16 weeks trial who took rilonacept and allopurinol was much lower than those on allopurinol and a placebo (duumy drug). And their gout attacks' frequency was reduced. It also seemed to be sufficiently safe. But a small number on rilonacept did withdraw from the trial.

So it may be able to help people through the period of gout attacks, during which many are discouraged from continuing a medication, because of the pain. And help too, perhaps, those gout patients who eventually end up with continuous pain for longer periods than usual in gout. This was tested in a small group in a phase one study.

It's too early to say exactly whether such discouragement will also be true of febuxostat (EU brand name: Adenuric, U.S. brand name Uloric) but in phase three trials of febuxostat, prior to U.S. and E.U. approval, quite a number of study patients suffered gout flares which caused them to discontinue the trial.

Arcalyst is a very interesting new gout drug and it could be a big step forward. We shall watch its progress closely and report in The Gout Dugout newsletter (see below) and on this page.

XOMA 052

Xoma 052 is a new gout medicine in an early stage of development. This one like arcalyst, (see above),acts as an anti-

Xoma 052 has a half life of 22 days which ultimately could mean less frequent dosing (it's injections) for gout patients. But it is years away from an approval application. However, any new gout drug that's an improvement on colchicine is more than welcome.

RDEA594 This text on RDEA594 will be updated soon.

At the European League Against Rheumatism (EULAR) meeting in Paris in June 2008 a possible new gout drug, currently called RDEA594, was presented. In an early human study it has demonstrated potent and fast reduction of uric acid.

RDEA806 is being developed as an anti-HIV medication, but the developing company learnt that RDEA806/RDEA594 also lowers uric acid. The developing company is not yet sure precisely how it works but it is likely to be a urosuric medication i.e. it improves the excretion of uric acid (UA).It will be developed as RDEA594, a metabolite of RDEA806.

The best figures presented at the EULAR meeting for RDEA806 were a mean (average) serum (blood) uric acid change from a baseline (i.e. starting level) of greater than 7.0 mg/dL of about 45% in ten days to two weeks. i.e. an average of UA 7.23 mg/dL down to 3.96 mg/dL. Reductions were largest in two patients who had higher initial starting levels of uric acid, which is nice to learn.

Rapid falls in uric acid levels often bring on gout attacks. So far the developing company has not reported this effect, but these are still fairly early days in this new gout drug's trials.

These figures are encouraging but it remains to be seen whether results would be as good if UA levels in a large group of patients, who started at much higher UA levels, were tested. That is, beginning at serum uric acid of 9.0 or 10.0 mg/dL or greater.

RDEA594 has many years of trial-studies ahead of it, before approval can come. Its trials continue.

Y-700

Another new gout drug is a compound currently known as Y-700. It is another xanthine oxidase inhibitor to reduce uric acid production. It still has to complete phase three trials, and maybe add-on extension trials. So it will be a number of years before Y-700 can be approved for use. Phase 3 trials take at least 3½ years. Y-700 has been described as being more effective than allopurinol.

URICASE-PEG 20

Uricase-Peg-20 is a different formulation of uricase (pegloticase)which may be more effective in certain more specific and difficult kinds of gout treatment. For example, patients who cannot tolerate allopurinol, patients with kidney disease, for tophaceous gout in some cases, gout with some kinds of cancer, and patients with gout attacks from organ transplant operations.

And, like pegloticase, this new gout drug is for people who have not reacted favourably to existing medications prescribed for gout attacks.

In November 2009, its developing company commenced a phase 1 study of it in tumor lysis syndrome and in patients with very difficult to treat gout. In an earlier phase 1 study it did show it could lower uric acid levels.

CANAKINUMAB

This is another of the new gout drugs for gout pain relief. It has been trialed at a dose of up to 150 mg against triamcinalone acetonide at 40 mg in 191 gout patients who could not take

colchicine or NSAIDs, or for whom NSAIDs don't work. On average, at 150 mg it achieved 50% gout pain relief in one day, a day faster than triamcinolone achieved a similar degree of relief for gout pain.

And the probability of subsequent gout flares with Canakinumab was just 3.7%, in its latest trial. This was very interesting news, which no doubt the developers will look into in more detail, because this medication is primarily for pain relief, not gout attacks' prevention. Arcalyst (rilonacept) has shown a similar capability.

This drug will also, if approved, compete in the pain relief market against Colchicine and Corticosteroids like prednisone. It will go into phase 3 trials.

If it's better than colchicine and corticosteroids (with their infamous side effects) gout sufferers who need to reduce the pain of attacks with these, will welcome it. Like arcalyst (rilonacept) and xoma 052, canakinumab is a biologic agent i.e. injections. It targets the Interleukin-1 inflammation excretion event, described in the copy above about arcalyst.

THE BOTTOM LINE

All these new gout drugs offer the possibility of improved gout treatment for more people. Despite the promise offered by Febuxostat (now approved for the U.S. and EU countries) and Pegloticase and Arcalyst(both not yet approved), they do not offer a complete solution for all gout sufferers. The drug which cures gout permanently, with certainty and completely, has still to be discovered.

A NEW GOUT DRUG TAKES A LONG TIME

Even if a pharmaceutical company, somewhere, is working on the ultimate cure, note that it understandably takes a long time for gout research to be done, new gout drugs developed and finally, approved by government regulatory agencies. The usual period quoted is 10 years, from the early stages of development to final approval.

For treating gout pain without drugs please visit our dealing with gout pain page.

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